After clearing an FDA hurdle, Amgen wins an FDA OK on CKD drug Parsabiv
Amgen barely managed to complete a full paragraph when the pharma giant announced last August that the FDA had rejected Parsabiv (etelcalcetide) for secondary hyperparathyroidism (SHPT), a disease that affects chronic kidney disease patients on hemodialyis. But the company managed to whip up something more in-depth when it announced last night that the agency had handed over an approval.
Regularly hailed as a top late-stage drug at Amgen $AMGN, investigators tested the drug in more than a thousand patients, reportedly meeting its primary endpoints by slashing dangerously high parathyroid hormone levels. In one study 74.7% of subjects on the drug hit its target, compared to just 8.9% in the placebo arm. In another Phase III trial the new drug outperformed Amgen’s blockbuster drug Sensipar, which earned $1.4 billion.
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